Status:
RECRUITING
Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Fibrosis Syndrome
Lymphedema
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
To find out if adding medication can help treat or prevent lymphedema and/or fibrosis related to radiation therapy, in survivors of head and neck cancer. Researchers will compare these drugs to find t...
Detailed Description
Primary Objectives 1. Determine the relative utility of candidate agents to reduce clinician-rated radiation lymphedema/fibrosis 1. Hyp 1: Participants receiving candidate agent(s) will exhibit a...
Eligibility Criteria
Inclusion
- Eligibility Criteria Eligibility criteria (observational registry or randomization)
- Prior history of head and neck cancer with no active disease.
- Treated previously with radiotherapy with prescribed dose (greater or equal to 30Gy) to unilateral or bilateral neck(s)
- Detectable CTC-AE G2+ lymphedema/fibrosis at \>6 months post-radiotherapy.
- No active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism, nor history of ulcers.
- No history of myopathy/rhabdomyolysis.
- Creatinine clearance \<30mL/min.
- No history of acute myocardial infarction or severe coronary disease.
- Non-pregnant/post-menopausal, or male.
- No history of diabetes mellitus
- Allergy/hypersensitivity to HMG Co-A reductase inhibitor and/or xanthine derivatives, e.g., caffeine, theophylline, theobromine
- No contraindications for magnetic resonance imaging a Subject to the discretion of the treating physician and Principal Investigator (PI), as the MRI may be optional
- Exclusion Criteria
- Active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism.
- History of myopathy/rhabdomyolysis.
- History of acute myocardial infarction or severe coronary disease.
- Pregnant/post-menopausal, or male.
- History of diabetes mellitus.
- Allergy/hypersensitivity to Hydroxymethylglutaryl-coenzyme A (HMG Co-A) reductase inhibitor and/or xanthine derivatives, e.g., caffeine, theophylline, theobromine.
- Contraindications for MRI Subject to the discretion of the treating physician and Principal Investigator (PI), as the MRI may be optional
- Participants who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to statins, hemorheologic agents or other agents used in study
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
Exclusion
Key Trial Info
Start Date :
August 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2033
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06912763
Start Date
August 8 2025
End Date
March 1 2033
Last Update
October 10 2025
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030